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ViroMed has more than 20 years of experience in the clinical
laboratory industry and more than a decade of experience serving the
tissue donor industry.
Key
features of ViroMed Laboratories’ reproductive and in vitro fertilization
(IVF) donor testing services include
Basic Donor Eligibility TestingSerology
Donor Eligibility RequirementsA donor eligibility determination based on screening and testing for relevant communicable agents and diseases is required for all donors of cells or tissues identified as human cell, tissue, and cellular- and tissue-based products (HCT/Ps)—including in vitro fertilization (IVF), sperm, and cellular or tissue implant donors—unless subject to exemption. Infectious disease testing must be performed in an FDA-registered laboratory. Tests approved by the FDA for diagnostic screening are not necessarily FDA-approved for screening HCT/P donors. Testing should be performed using tests that have been licensed, approved, or cleared by the FDA specifically for use in donor screening (when available) or approved/cleared for use in low prevalence, asymptomatic populations.Basic testing for donor eligibility determination
Additional
tests for donors of leukocyte-rich cells and tissue Additional tests for reproductive donors
ViroMed’s Reproductive Donor
Panels
139060 - FDA Guidance Female Reproductive Donor Panel (without reflex) 139061 - FDA Guidance Female Reproductive Donor Panel (with reflex) 139062 - FDA Guidance Male Reproductive Donor Panel (without reflex) 139063 - FDA Guidance Male Reproductive Donor Panel with reflex) Click here
for Other Donor Panels & Tests The FDA released Guidance
for Industry: Eligibility Determination for Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in August 2007.
Visit http://www.fda.gov/cber/gdlns/tissdonor.htm
to view a copy of
this document online.
The
federal guidance assists establishments in complying with donor
eligibility determinations as set forth in Title 21 Code of Federal
Regulations, part 1271, subpart C.
This guidance applies to cells and tissues procured on or after May
25, 2005. Specimens for testing should be obtained at the same time as
cells or tissue are recovered from the donor. In the case of oocytes, a specimen
may be collected for testing as long as 30 days before donation. For anonymous semen donors, a new
specimen should also be collected at least six months after the date of
donation and tested for relevant communicable diseases. For more information about ViroMed’s comprehensive menu of donor testing
services , please call client services
at 800-582-0077.
Comprehensive Laboratory Services for Reproductive and Infertility Specialists
Direct Shipping System for Reproductive Donor Eligibility Testing
ViroMed’s direct shipping system can assist in ensuring timely receipt of specimens for time-sensitive infectious disease testing such as donor eligibility screening that must be performed according to FDA guidance. ViroMed is an FDA-registered laboratory for human cells, tissues, and cellular- and tissue-based products (HCT/Ps). For clarification about when to use the direct shipping system, please contact ViroMed client services at 800-582-0077.
Click here for ViroMed direct shipping system details and ordering information Answers to Your QuestionsIf you have any questions or concerns, please call ViroMed Client Services at 800-582-0077.
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